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NCT03351478 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 770
- Enrollment target
NCT03351478: Completed Phase 3 study, sponsored by Lexicon Pharmaceuticals.
NCT03351478 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 770 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03351478, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 770 participants
- Enrollment target
Study Summary
The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.
Primary Outcome
An analysis of covariance (ANCOVA) model was used for the analysis.
Interventions
- DRUG Placebo
- DRUG Empagliflozin
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 770 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2019-05-16 |
| Phase | Phase 3 |
What the finished NCT03351478 record still lists
NCT03351478 is an interventional study that assigns participants to a tested intervention. The registered 770 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03351478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03351478 about?
NCT03351478 is a clinical study titled "Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin". The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.
What is the current status of trial NCT03351478?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 770 participants. The study started on 2017-11-27. Estimated completion is 2019-05-16.
What interventions are being tested in trial NCT03351478?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03351478?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03351478's enrollment target sits among peer trials
770 440th of 2000 higher than 1,557 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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